Artificial airway management devices, systems and methods

ABSTRACT

Systems and methods for cleaning and maintaining artificial airways sized for insertion within pediatric or neonatal patients (e.g., external diameters of less than 5 mm) are disclosed. The system includes a multi-port ventilator manifold configured to couple to a ventilation source, thereby forming a ventilator circuit with the patient. The manifold includes an occluder configured to advantageously reduce an amount of dead space in the manifold so as to prevent loss of positive end expiratory pressure of the ventilator circuit and reduce the likelihood of broncho-pulmonary dysplasia of the patient, or even premature death.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/441,037 filed on Dec. 30, 2016, the entire content of which ishereby incorporated by reference herein. This application is related toPCT Publication No. WO 2015/187583, the entire content of which ishereby incorporated by reference herein.

FIELD

Embodiments disclosed herein relate generally to devices, systems andmethods for cleaning of artificial airways or body-inserted tubes (e.g.,endotracheal tubes) and/or for airway management.

BACKGROUND

During an intubation procedure, endotracheal tubes can be placed inpatients who are unable to effectively maintain life-sustainingventilation and respiration on their own. An endotracheal tube is usedin patient care to ensure a clear airway through the mouth, pharynx, andtrachea into the lungs. Use of an endotracheal tube is appropriate whenthe integrity of the airway is, or may become, challenged due to traumaor pathology, or if a patient cannot otherwise breathe unaided. Oftenthe endotracheal tube is coupled to a mechanical ventilator to aid thepatient's respiration, and can be expected to remain in situ for anextended time until the patient is once again able to breathe on his orher own. The endotracheal tubes can be inserted within a patient'snative airway for short periods of time (e.g., for a matter of hoursduring anesthesia for surgery) or the endotracheal tubes can remain inplace to provide ventilator-assisted breathing for days or weeks.

The institution of mechanical ventilation can result in increasedproduction of secretions within the patient's native airways andaccumulation of those secretions within an artificial airway such as anendotracheal tube. The insertion of an endotracheal tube within thepatient's trachea renders the normal cough mechanism for clearing ofsecretions ineffective, as the patient cannot transiently close theglottis to build up pressure in the airway that, when released, helpsexpel secretions. Also, the mucociliary system which helps transportsecretions and debris from the tracheobronchial tree into the tracheafor expectoration becomes ineffective in the sick, intubated patient.The secretions, therefore, can pool in dependent portions of the lungover time due to gravity and, if not removed in a timely manner, canresult in ventilator-acquired pneumonia (VAP) or other undesiredconditions or ailments. Closed suction systems may be coupled to theendotracheal tube and a suction catheter may be used to suction out thepooled secretions or other debris within the patient's native airwaysand/or the endotracheal tube. Intraluminal volume loss attributable tothe accumulation of secretions on the interior wall of endotrachealtubes is not prevented by standard suctioning treatment. Secretionaccumulation can lead to life-threatening occlusion of the endotrachealtube or at least increased work of breathing, which may result inincreased difficulty in weaning, and prolonged mechanical ventilationand intensive care unit stay, especially for neonatal andpediatric-sized endotracheal tubes. Additionally, secretion accumulationon the inside of the endotracheal tube leads to colonization withpotentially pathological organisms and this colonization is likewiseimplicated in the development of VAP.

SUMMARY OF DISCLOSURE

In accordance with several embodiments, a system for maintenance of anartificial airway includes one or more cleaning modules (e.g., suctioncatheter module, endotracheal tube cleaning module, visualizationmodule) adapted to be removably and interchangeably coupled to an accessport of a manifold that is adapted to be coupled to a body-insertedmedical tube (e.g., endotracheal tube). The manifold may include aventilator port adapted to couple to a standard ventilation source(e.g., ventilator or ventilation unit) so as to provide ventilation to apatient from the ventilator through the artificial airway. The cleaningmodules may include instruments configured to access and/or treat theartificial airway (e.g., endotracheal tube) and/or tracheobronchialtree. The access port of the manifold can be reversibly closed (e.g.,via an occluder such as a stopcock or barrier valve that can rotate inand out of an occluding or blocking configuration) to the patient andventilator port of the manifold. The artificial airway maintenancesystem may be specifically adapted (e.g., sized and constructed) tofacilitate safe and effective cleaning of artificial airways (e.g.,endotracheal tubes) sized to be used in pediatric or neonatal patients(e.g., less than 7 mm in external diameter, less than 5 mm in externaldiameter, less than 4 mm in external diameter, less than 3 mm inexternal diameter, 2.5 mm or less in external diameter). In variousembodiments, the modules are configured as closed system modules thatinclude a flexible sheath configured to, during use, prevent exposure ofa portion of the module and/or the artificial airway to an externalenvironment.

The endotracheal tube cleaning module may include a catheter having anexpandable cleaning member configured to wipe an interior surface of theartificial airway (e.g., endotracheal tube) to remove biofilm or otherdebris accumulated thereon. The expandable cleaning member may have asmooth, regular profile. In some embodiments, the expandable cleaningmember comprises one or more rings, shavers or other wiper members. Therings, shavers or other wiper members may comprise one or more shearingor squared (or substantially squared) edges or may comprise a smoothcontact surface with generally rounded edges. In various embodiments,the expandable cleaning member is pneumatically expandable ormechanically expandable. In some embodiments, at least one activationmember is configured to compress a fluid or gas reservoir in fluidcommunication with the expandable cleaning member, thereby causing theexpandable cleaning member to expand (e.g., inflate). The activationmembers may comprise plungers, syringes, buttons or other devicesconfigured to be activated by a single actuation motion with a singlepress or touch of a finger. In some embodiments, upon expansion of theexpandable cleaning member, at least a portion of the expandablecleaning member is configured to contact an interior surface of abody-inserted tube (e.g., endotracheal tube) such that, when thecatheter is withdrawn from the body-inserted tube, biofilm (e.g., debrisor secretions) collected on the interior surface is removed by theexpandable cleaning member. The suction catheter cleaning device moduleincludes a coupling member configured to couple to a suction port of amulti-port manifold or endotracheal tube adapter (e.g., dual-port ortri-port adapter). In one embodiment, the suction catheter cleaningdevice module includes a suction catheter configured to clean theinterior surfaces of body-inserted tubes or artificial airways (alone orin addition to suctioning natural airways or portions of the respiratorytract or other body lumens).

The manifold or endotracheal tube coupling adapter may include multipleports, such as a ventilator port, an instrumentation port and a distalport. The distal port may be configured to directly or indirectly (e.g.,via a universal endotracheal tube connector) couple to an artificialairway (e.g., endotracheal tube). In some embodiments, the manifold orendotracheal tube adapter is transparent to facilitate viewing ofmarkings (e.g., centimeter markings) on the catheters of the modulesbeing inserted into the artificial airway through the manifold that areindicative of depth of insertion within the artificial airway (e.g.,endotracheal tube), thereby preventing against over-insertion. Themarkings on the catheters may correspond to similar markings on theartificial airway (e.g., endotracheal tube).

In some embodiments, the expandable cleaning member of the endotrachealtube cleaning device includes a lubricant (e.g., a SURGILUBE lubricant)and/or a bactericide or antibacterial agent (e.g., chlorhexidine). Thecleaning member alone, the catheter alone, or both the catheter and thecleaning member may be treated so that a bonded or integral lubriciouscoating (e.g., parylene) may facilitate insertion of the catheter andwithdrawal of the catheter and deployed cleaning member. In oneembodiment, the bactericide is activated by photodynamic means.

In accordance with several embodiments, a method for cleaning anendotracheal tube and/or distal airways (e.g., tracheobronchial tree)without removing a pediatric or neonatal patient from a ventilator isprovided. In one embodiment, the method comprises coupling anendotracheal tube adapter or manifold to the endotracheal tube. In oneembodiment, the endotracheal tube adapter or manifold comprises multipleports, such as a distal coupling port, a ventilator port, and an accessor instrumentation port. The method may further comprise removablyconnecting (e.g., via friction-fit engagement or mechanical interlockingengagement) a coupling member of a suction catheter system or module tothe instrumentation port of the endotracheal tube adapter or manifold.In one embodiment, the suction catheter system or module includes asuction catheter and a flexible sheath configured to enclose the suctioncatheter when it is withdrawn from the endotracheal tube so as toprovide a closed system.

The method further comprises coupling a ventilator to the ventilatorport of the endotracheal tube adapter or manifold and inserting a distalend of the suction catheter through at least a portion of anendotracheal tube to perform suctioning of the endotracheal tube and/orportions of the tracheobronchial tree beyond the endotracheal tube.Ventilation may advantageously be maintained during performance of theentire method. In some embodiments, the manifold comprises a stopcock orother valve control adapted to open and close access to the endotrachealtube by the suction catheter and/or other instruments while stillmaintaining ventilation. The stopcock may include an occluder or barrierconfigured to seal off the manifold from exposure to the externalenvironment or the flexible sleeve of a closed suction system modulethrough the access or instrumentation port. An occluder may be toggledto an open configuration prior to insertion of the suction catheter. Inone embodiment, the method includes decoupling the suction cathetercleaning module from the instrumentation port of the manifold. Anoccluder may be toggled to a closed or blocking configuration prior toremoval of the suction catheter cleaning module so as to prevent air andpositive ventilation pressure (e.g., positive end expiratory pressure)from leaking out of the manifold.

Either soon after removal of the suction catheter cleaning module (e.g.,within a matter of seconds, 30 seconds to 5 minutes) or after a longerperiod of time (e.g., minutes to hours after), the method may furtherinclude removably coupling an endotracheal tube cleaning device moduleto the instrumentation port. The endotracheal tube cleaning devicemodule includes a catheter having an expandable cleaning memberpositioned along a distal end portion of the catheter. The method mayinclude advancing the catheter such that the expandable cleaning memberis at or near a distal end of the endotracheal tube and then expandingthe expandable cleaning member into an expanded configuration such thatat least a portion of the expandable cleaning member is in contact withan interior surface of the endotracheal tube. The method may furtherinclude withdrawing the catheter from the endotracheal tube with theexpandable cleaning member in the expanded configuration to effectivelyremove biofilm or debris that is accumulated on the interior surface ofthe endotracheal tube that may not have been suctioned out by thesuction catheter (either because it was missed or because it is adheredin a manner that suctioning is not sufficient to remove it). Thecatheter may be removed from the endotracheal tube and out of themanifold into a cleaning chamber of the endotracheal tube cleaningdevice module. The endotracheal tube cleaning device module may includean irrigation port in communication with the cleaning chamber so as tofacilitate irrigated cleaning of the cleaning member to facilitatereuse. An occluder may be toggled to a closed or blocking configurationafter withdrawal of the catheter beyond the position of the occluder soas to prevent irrigation fluid from entering the artificial airway (andthus distal airways as well) and/or to prevent loss of positiveventilatory circuit pressure when the endotracheal tube cleaning devicemodule is decoupled from the instrumentation port.

In some embodiments, the method comprises suctioning distal airways of apatient using the suction catheter. In one embodiment, the methodcomprises cleaning a distal tip of the suction catheter through anirrigation port either of the manifold or of the suction cathetercleaning module. In some embodiments, the method comprises collecting aportion of the removed biofilm for microbiologic evaluation. The methodmay comprise identifying a type of bacteria present within the removedbiofilm (such as by polymerase chain reaction, infrared light detection,or other real-time or substantially real-time diagnostic or evaluationmethods).

In accordance with several embodiments, a visualization device moduleconfigured to provide visualization of a patient's airways is provided.In one embodiment, the visualization device module includes a distalcoupling member configured to couple to the instrumentation port of themanifold. In one embodiment, the visualization device module includes avisualization device (e.g., bronchoscope) sized and configured to extendfrom a mouth of a patient to distal portions of the respiratory tree ofa patient. In one embodiment, the visualization device module includes aflexible sleeve coupled to the distal coupling member and extendingproximally therefrom to enclose the visualization device when thevisualization device is outside of the patient, thereby isolating thevisualization device from exposure to outside air or externalcontamination. In one embodiment, the visualization device (e.g.,flexible fiber optic scope) may be introduced via an angled irrigationport of a closed system manifold including a seal or mechanicalcoupling. In some embodiments, the visualization device includes asuction lumen, a visualization lumen, and/or an irrigation lumen. Any ofthe modules described above may be interchangeably coupled to themanifold multiple times without disconnecting the patient from theventilator and without loss of positive ventilatory circuit pressurethrough the manifold because of the rotatable occluder.

In some embodiments, the suction catheter has an outer diameter that isless than 70% (e.g., 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%)of the inner diameter of the body-inserted tube (e.g., endotrachealtube, chest drainage tube, urinary catheter). The outer cross-sectionaldimension of the suction catheter may be sized such that the suctioncatheter does not significantly compromise airflow during its insertion,or during suctioning and removal. In one embodiment, the outer diameterof the suction catheter is less than 50% of the inner diameter of thebody-inserted tube. In one embodiment, the outer diameter of the suctioncatheter is no larger than 70% of the diameter of the lumen of thebody-inserted tube.

According to some embodiments, a kit (e.g., system or collection ofitems for a common purpose) for removing biofilm (e.g., debris) that hascollected within one or more airways (e.g., native airway, oral cavity,nasal passages, pharynx, larynx, trachea, and/or any portion of thelungs, including any of the branches of the tracheobronchial tree,endotracheal tube, etc.) of a patient is provided. The term “kit” asused herein should be given its ordinary meaning and should include anysystem, grouping and/or collection of devices, systems, modules,components, features, materials and/or the like provided for a commongoal. In one embodiment, the kit includes one or more of the following,depending on the needs or clinical situations handled by the patientcare facility: an artificial airway (e.g., endotracheal tube or otherbody-inserted tube), an endotracheal tube cleaning device or module, asuction catheter or cleaning module, a visualization device or module(e.g., bronchoscope), a multi-port manifold or endotracheal tubeadapter, accessory caps, and/or any other system, device or component.The kit can further comprise instructions for using the various devices,components and/or other features of the kit for a particular cleaningprotocol or procedure. For example, such instructions for use caninclude details regarding the order in which the devices, systems orother components are used, the duration of use and/or the like.

In some embodiments, one or more ports of the adapters or manifoldsdescribed herein can be shaped, angled or curved in a similar manner asthe device being introduced through the port to aid in the ease ofintroduction, removal and collection of organized secretions or biofilm.The adapters or manifolds can be connected to any tube-like structure,including, but not limited to, endotracheal tubes, percutaneoustracheostomy devices, urinary catheters, or dialysis catheters, chesttubes, or other catheters and tubes.

In accordance with some embodiments of the invention, the adapters ormanifolds can be used with “closed suction” systems. The adapter ormanifold can include three ports, with one port or tube for connectionto oxygen tubing or directly to a ventilator, one port or tube forinstrumentation access, and one port to connect to an artificial airway(e.g., endotracheal tube). The ventilator port and the instrumentationaccess port may form a Y connection to the distal port. The occluder maybe positioned just proximal to the intersection of the two ports formingthe Y so as to advantageously reduce or minimize the amount ofventilatory dead space within the manifold. The manifold can beconfigured to be used multiple times or a single time. Any ports ortubes not in use can be sealed and capped.

In some embodiments, the suction catheter cleaning module and/or theendotracheal tube cleaning device module includes a polymeric tubularextension or proboscis coupled to the manifold and extending into theflexible enclosure, wherein the tubular extension is configured toreceive a flexible catheter and pull the flexible catheter at leastpartially into the body-inserted tube through the manifold. Thepolymeric tubular extension may be particularly advantageous for soft,pliable catheters or instruments and/or catheters having outer diametersof less than 5 mm (e.g., catheters designed for neonate or pediatricpatients).

According to some embodiments, the devices and/or systems disclosedherein are advantageously disposable and relatively inexpensive tomanufacture. Thus, such embodiments do not require subsequent cleaning,sterilization, and repackaging. Some embodiments are advantageousbecause they can be performed via the natural airway of a patient whilea patient undergoes assisted ventilation utilizing an endotracheal ortracheostomy tube.

In several embodiments, the cleaning device is particularly advantageousbecause it rejuvenates endotracheal tubes that have been clogged orotherwise contaminated with biofilm. In one embodiment, the cleaningdevice removes biofilm such that endotracheal tube resistance isdecreased by at least 20% after cleaning, thus enhancing thefunctionality of the endotracheal tube. In some embodiments, thecleaning device removes greater than 99% of bacteria (as determined bycolony counts in the biofilm) from the endotracheal tube. Thus, inseveral embodiments, the cleaning device offers significant economic andclinical benefits. Some embodiments disclosed herein are particularlyadvantageous because they do not require performance by a physician anddo not require sedation, short acting paralytics, increased intravenousfluid administration, and/or vasopressors. Some embodiments of theinventions are advantageous because they are minimally invasive and theyminimize pain and discomfort to the patient and minimize the overalltime of cleaning. Some embodiments of the inventions reduce the numberof times that suctioning must be performed in a twenty-four hour period.

In accordance with several embodiments, a system for maintenance of anartificial airway (e.g., endotracheal tube) having an external diameterof less than 5 mm (e.g., less than 5 mm, less than 4 mm, less than 3 mm,2.5 mm or less) includes a multi-port manifold or adapter. The manifoldincludes two proximal ports and one distal port. The proximal portsinclude a ventilation port configured to be removably coupled to aventilator and an access port configured to be removably coupled tomultiple modules adapted to access and/or treat the artificial airway(e.g., endotracheal tube) through the manifold. The distal port isconfigured to be removably coupled to the artificial airway (e.g., viafriction-fit, mechanical interlock or other engagement mechanism). Theventilation port and the access port branch off from a main body of themanifold to form a Y shape. The manifold further includes an occluder(e.g., stopcock or valve) positioned at or near a location along alength of the manifold at which the ventilation port and the access portbranch off from the main body of the manifold. The occluder isconfigured to transition between an open configuration and a closedconfiguration. In the closed configuration, a lumen of the manifold incommunication with the distal port and a lumen of the ventilator portare sealed off from a lumen of the access port. In this embodiment, theoccluder includes an external knob and an internal barrier (e.g.,sealing member) extending laterally from the external knob. The internalbarrier of the occluder is shaped and sized so as to effectively sealoff the access port from the remainder of the manifold (e.g., the distalport and the ventilator port) when the occluder is in the closedconfiguration, thereby reducing an amount of dead space of a ventilatorycircuit within the manifold. The barrier or sealing member may besubstantially planar so as not to interfere with introduction ofinstruments when the occluder is in the open configuration. In someembodiments, the knob is configured to be rotated 90 degrees totransition between the open configuration and the closed configuration.

The system may further include a suction catheter module configured tobe removably coupled to the access port of the manifold. The suctioncatheter module includes a suction catheter configured to be introducedinto the artificial airway (e.g., endotracheal tube) through themanifold and to suction out accumulated biofilm from the artificialairway and/or portions of a tracheobronchial tree distal to theartificial airway. The system may also include an artificial airwaycleaning device module (e.g., endotracheal tube cleaning device module)configured to be removably coupled to the access port of the manifold.The artificial airway cleaning device module includes a flexiblecatheter having a distal expandable cleaning member, the flexiblecatheter being configured to be introduced through the manifold into theartificial airway. The distal expandable member is configured to beexpanded into contact with an interior surface of the artificial airway(e.g., endotracheal tube). The flexible catheter is configured to bewithdrawn from the artificial airway with the distal expandable memberin an expanded configuration to remove additional biofilm (e.g., themore dense secretions or the secretions that are more tightly adhered tothe surface of the artificial airway) from the artificial airway. Theartificial airway may be an endotracheal tube designed for insertionwithin pediatric and/or neonatal patients and may have an externaldiameter of less than 7 mm, less than 5 mm, less than 4 mm, less than 3mm, 2.5 mm or less).

In some embodiments, the artificial airway cleaning device moduleincludes a syringe configured to transition the distal expandablecleaning member from an unexpanded configuration to the expandedconfiguration. The flexible catheter of the artificial airway cleaningdevice module includes a pilot channel extending from the syringe to thedistal expandable cleaning member. The syringe may be adapted to providea fixed volume of air sufficient to inflate the expandable cleaningmember into the expanded configuration. The fixed volume of air may be apredetermined amount based on the diameter of the artificial airway(e.g., endotracheal tube) into which the artificial airway cleaningdevice is designed to be inserted. For example, a chamber of the syringemay include a pre-drilled hole positioned at a location along thechamber of the syringe so as to provide the fixed volume of air, therebyproviding controlled expansion and avoiding overexpansion of theexpandable cleaning member.

In some embodiments, the suction catheter module includes a flexiblesheath extending from a proximal portion of the suction catheter moduleto a distal connector configured to couple to the access port of themanifold so as to provide a closed suction system. The artificial airwaycleaning device module may include a flexible sheath extending from aproximal connector to a distal connector configured to couple to theaccess port of the manifold so as to provide a closed system.

In some embodiments, the artificial airway cleaning device moduleincludes a conical extension member (e.g., proboscis) extending from thedistal connector to a location along a length of the catheter, whereinan outer cross-sectional dimension of the conical extension memberdecreases from a distal end of the extension member to a proximal end ofthe extension member, and wherein the conical extension member isconfigured to facilitate entry of the flexible catheter into themanifold and gathering of the flexible sheath such that the flexiblesheath does not substantially interfere with advancement of the flexiblecatheter into the manifold. The artificial airway cleaning device modulemay include an irrigation port configured to facilitate introduction ofirrigating fluid to clean the expandable cleaning member after thecatheter is removed from the manifold.

In accordance with several embodiments, a method of cleaning anendotracheal tube inserted within a body of a pediatric or neonatalpatient without disconnecting the patient from a ventilator and withoutremoving the endotracheal tube from the body is disclosed. The methodincludes coupling a distal port of a multi-port manifold to anendotracheal tube having an external diameter of less than 5 mm (e.g.,less than 5 mm, less than 4 mm, less than 3 mm, 2.5 mm or less). Themethod also includes coupling a first proximal port of the manifold to aventilation source (e.g., ventilator or ventilation unit). The methodfurther includes reversibly coupling (e.g., via friction-fit, mechanicalinterlocking or other engagement mechanism) a suction catheter cleaningmodule to a second proximal port of the manifold, the suction cathetercleaning module including a suction catheter sized to fit within theendotracheal tube. The method includes advancing a distal end of thesuction catheter through the distal port of the manifold and into theendotracheal tube and activating a suction source so as to facilitateremoval of biofilm from the endotracheal tube through one or moresuction ports at the distal end of the suction catheter. The method mayoptionally include advancing the distal end of the suction catheterbeyond an open distal end of the endotracheal tube to suction distalairways (e.g., portions of the tracheobronchial tree). The methodfurther includes decoupling the suction catheter cleaning module fromthe second proximal port of the manifold.

The method may further include reversibly coupling (e.g., viafriction-fit, mechanical interlocking or other engagement mechanism) anendotracheal tube cleaning module to the second proximal port of themanifold. The endotracheal tube cleaning module includes a flexiblecatheter having an expandable cleaning member positioned along a distalend portion of the flexible catheter. The method may also includeperforming a cleaning procedure within the endotracheal tube byexpanding the expandable cleaning member into an expanded configurationsuch that at least a portion of the expandable cleaning member is incontact with an interior surface of the endotracheal tube and thenwithdrawing the flexible catheter proximally out of the endotrachealtube with the expandable cleaning member in the expanded configuration.The endotracheal tube cleaning module may be decoupled from the secondproximal port of the manifold after performing the cleaning procedure.

In some embodiments, the method includes introducing fluid through anirrigation port of the endotracheal tube cleaning module to clean theexpandable cleaning member after decoupling the endotracheal tubecleaning module from the second proximal port of the manifold. Themethod may also include enabling access to the distal port of themanifold and the endotracheal tube by causing an occluder of themanifold to transition to an open configuration from a closedconfiguration prior to the step of advancing a distal end of the suctioncatheter through the distal port of the manifold and into theendotracheal tube, thereby providing unobstructed access through themanifold. The method may further include occluding the manifold so as toprevent loss of positive end expiratory pressure in a ventilatorycircuit due to dead space in the manifold proximal to a Y junctionformed by the first proximal port and the second proximal port.

In accordance with several embodiments, a connector interface includes adistally-tapered outside end and a proximally-tapered conical inside endfor collection and retention of debris removed from a tube by a catheteror other instrument inserted through the connector interface. Theconnector interface may also include a side port positioned along alength of the connector interface between a proximal end and a distalend of the connector interface that is adapted for providing irrigationcleaning of the catheter or instrument.

In accordance with several embodiments, a sterilization device adaptedto removably couple (e.g., via friction-fit, mechanical interlocking orother engagement mechanism) to a catheter or other device (e.g., asuction catheter of a suction catheter device module, a suction catheterdevice module, a catheter of an artificial airway cleaning devicemodule, an endotracheal tube cleaning module, a visualization devicemodule). The sterilization device includes a proximal end having anultraviolet-C (UV-C) light source and a coupling mechanism adapted toremovably couple (e.g., via friction-fit, mechanical interlocking orother engagement mechanism) to the catheter or other device. Thesterilization device includes a power switch adapted to prevent lightemission when the sterilization device is not coupled to the catheter orother device. The sterilization device may also include an integratedtimer configured to ensure proper duration of light emission by the UV-Clight source. The sterilization device may further include an indicatorlight adapted to indicate when the sterilization device is active and/orwhen a light delivery cycle is complete. In embodiments incorporatingrechargeable power sources, the sterilization device can include arecharging interface adapted to recharge the one or more rechargeablepower sources. In one embodiment, the sterilization device includes alow power indicator. In one embodiment, the sterilization deviceincludes quartz protuberances adapted to transmit UV-C light deeper intoa cleaning chamber of the catheter or other device.

For purposes of summarizing the disclosure, certain aspects, advantagesand novel features of embodiments of the inventions have been describedherein. It is to be understood that not necessarily all such advantagescan be achieved in accordance with any particular embodiment of theinventions disclosed herein. Thus, the embodiments disclosed herein canbe embodied or carried out in a manner that achieves or optimizes oneadvantage or group of advantages as taught herein without necessarilyachieving other advantages as can be taught or suggested herein. Themethods summarized above and set forth in further detail below describecertain actions taken by a practitioner; however, it should beunderstood that they can also include the instruction of those actionsby another party. Thus, actions such as “inserting a suction catheter”include “instructing the insertion of a suction catheter.” Furtheraspects of embodiments of the invention will be discussed in thefollowing portions of the specification. With respect to the drawings,elements from one figure may be combined with elements from the otherfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of a pediatric and/or neonatal airwaymanagement system.

FIG. 1A illustrates a close-up view of a portion of a manifold, orconnector, of the airway management system of FIG. 1.

FIG. 2 illustrates an embodiment of an endotracheal tube cleaning devicemodule. FIG. 2A illustrates a cross-section view of an embodiment of aconnector (e.g., distal connector of the cleaning device of FIG. 2)adapted to couple to an endotracheal tube or manifold. FIG. 2Billustrates an embodiment of a system that includes a cleaning devicecatheter module and a manifold, wherein the system is adapted to allowinterchangeable connection of modules without loss of pressure or abreak in ventilatory circuit.

FIGS. 3A and 3B illustrate a portion of an embodiment of a cathetershaft of the cleaning device module of FIG. 2 that includes a coextrudedmaterial (before and after a curing process, respectively).

FIG. 4 illustrates a close-up view of the distal end portion of thecleaning device module of FIG. 2 that shows the tubular extension (orproboscis) extending into the sheath.

FIG. 5 illustrates an embodiment of a sterilization cap. FIG. 5Aillustrates an embodiment of a window within the sterilization cap ofFIG. 5.

FIG. 6A illustrates a perspective view of an embodiment of the manifoldwith the access port lumen closed.

FIG. 6B illustrates a perspective view of the embodiment of the manifoldof FIG. 6 with the access port lumen opened.

FIG. 7 illustrates a prior art manifold having dead space from at leastthe intersection of the “Y” branches with the main body of the manifoldto the catheter irrigation connection.

FIG. 8 illustrates an embodiment of the manifold of FIGS. 6A and 6Bcoupled with a suction catheter module and shows that the dead space hasbeen eliminated proximal of the intersection of the “Y” branches withthe main body of the manifold.

FIG. 9 illustrates an embodiment of a tubular, or cap, extension memberconfigured for use with a suction system.

FIGS. 10A and 10B illustrate one embodiment of a distal portion of asuction catheter device comprising an expandable cleaning portion.

FIGS. 11A-11C illustrates various views of an embodiment of a suctioncatheter device comprising an expandable cleaning portion positionedwithin an interior of an endotracheal tube or other body inserted tube.

DETAILED DESCRIPTION

Several embodiments of cleaning systems, devices and methods describedherein are particularly well-suited to remove biofilm (e.g., secretions,debris and/or other materials) from body-inserted tubes (e.g.,endotracheal tubes) and the respiratory tract or tree of a patientwithin a closed or partially closed suction system while a patient isconnected to a ventilator The various devices, systems, methods andother features of the embodiments disclosed herein may also be utilizedor applied to other types of apparatuses, systems, procedures, and/ormethods, whether medically related or not. For example, the embodimentsdisclosed herein can be utilized for, but are not limited to,bronchoscopes, chest drainage tubes, gastrostomy drainage tubes,abdominal drainage tubes, other body drainage tubes, feeding tubes,endoscopes, percutaneous dialysis catheters, urinary catheters, urethralcatheters, Foley catheters, and any other percutaneous or per oscatheters or body-inserted tubes.

The materials used for the various components of the cleaning and/orvisualization devices and systems described herein can advantageouslycomprise one or more biocompatible materials. Such materials can berigid or semi-rigid and/or flexible, as desired or required for aparticular application or use. The materials used can include, but arenot limited to, polyether ether ketone (PEEK), Nylon 6/6, polyethylene,polypropylene, polyethylene terephthalate (PET), glycol-modified PET,polyvinyl chloride (PVC), thermoplastic elastomers (TPEs) such as PEBAXTPEs, other natural or synthetic polymers (e.g., KRATON polymers),silicone, natural rubber, latex, polycarbonate, K resin, acrylonitrilebutadiene styrene (ABS), styrenes and/or other thermoplastic elastomersor polymers.

The terms “debris” and “secretions” as used herein shall be given theirordinary meaning and shall include, without limitation, biologicalfluids, solids, gels, deposits, films, debris, and/or secretions, suchas mucosal secretions, blood, bacteria, biofilm, viruses, othermicroorganisms, protein, feces, urine, albumin and/or any otherbiological or biologically-related materials. The term “nativeairway(s)” as used herein shall be given its ordinary meaning and shallinclude, without limitation, the oral cavity, nasal passages, pharynx,larynx, trachea, and/or any portion of the lungs, including any of thebranches of the tracheobronchial tree.

The term “biofilm” as used herein shall be given its ordinary meaningand shall include, without limitation, biological fluids, solids, gels,deposits, films, debris, and/or secretions, such as mucosal secretions,blood, blood clots, bacteria, viruses, other microorganisms, protein,feces, urine, albumin and/or any other biological orbiologically-related materials. In some embodiments, the biofilm maycomprise any debris that can be deposited and come to rest within alumen of an endotracheal tube, such as blood clot material, mucus,secretions, biofilm, or any other type of particulate matter that mightfind itself within the lumen of an endotracheal tube. In someembodiments, the biofilm may comprise any debris collected or removedfrom native airways of a patient or from a body-inserted tube.

Conventional closed suction catheter cleaning and optimal humidificationdoes not adequately keep endotracheal tubes free of accumulatedsecretions or microbial colonization and biofilm formation. While thisaccumulation of secretions in larger adult-sized endotracheal tubes isclinically significant and requires removal for best patient outcome,even the smallest bit of retained secretions in pediatric and neonatalsized endotracheal tubes (e.g. tubes having an inner diameter of lessthan 7 mm or between 2.0 and 6.5 mm) imposes a critical restriction inairflow and much increased work of breathing. This is because resistanceto airflow in a tube is inversely proportional to the radius of the tubeto the fourth power, as expressed in Pouseille's equation:

$R = \frac{8\; {nL}}{\pi \; r^{4}}$

Smaller tubes have very high resistance to begin with, and any residualobstruction may contribute to ongoing respiratory failure in the childor neonate. It is also well appreciated that retained secretions andmicrobial colonization result in biofilm formation within essentiallyall endotracheal tubes over time, that biofilm is at least part of thepathophysiology of ventilator associated pneumonia, and that everyeffort should be made to eliminate its development within theendotracheal tube or other body-inserted tube.

Due to the limitation in suction negative pressure that can be applied(e.g., 80 cm H₂O), the small size of suction catheters themselves, andthe need to keep the suction catheters smaller than the internaldiameter of the endotracheal tube, suctioning alone invariably leavessome secretions and debris behind in endotracheal tubes sized andconfigured for pediatric or neonatal patients (e.g., pediatric andneonatal-sized tubes having an internal diameter of less than 7 mm, suchas between 2.0 and 6.5 mm). In order to try and clear the pediatric orneonatal-sized tube better, practitioners sometimes use suctioncatheters larger than recommended to try to “bulldoze” a clearer pathbecause they do not want to have to exchange the endotracheal tube. As alast resort, but entirely too often, endotracheal tubes have to beexchanged, which can result in severe adverse consequences to thepatient, including death. What is needed is a device that can safely,efficiently, and effectively remove the retained secretions and debristhat standard suction (open or closed) systems leave behind and to beable to do so in even the smallest of endotracheal tubes (e.g.,pediatric and neonatal-sized tubes having an internal diameter of lessthan 7 mm, such as between 2.0 and 6.5 mm).

FIG. 1 illustrates one embodiment of a pediatric and neonatal-sizedairway management, or maintenance, system 10. The illustrated system 10is a closed suction system; however, at least some of the componentscould be used in a non-closed or open suction environment in alternativeembodiments. In various embodiments, the pediatric and neonatal-sizedairway management system 10 allows for, or facilitates, suctioning,endotracheal tube cleaning, administration of fluids and/or light,visualization of the endotracheal tube and distal airways, and/orintroduction of other instrumentation, as desired and/or required.Pediatric and neonatal suction systems (whether open or closed) mayrequire transient removal to effectively clean the smallest (about 2.0mm and up) ET tubes. In accordance with several embodiments, thepediatric and neonatal-sized airway management system 10 facilitatescleaning using an endotracheal tube cleaning device sized to fit withina pediatric and neonatal-sized endotracheal tube without breaking theventilatory circuit, thereby reducing the likelihood of hypoxemia, lossof tidal volume, loss of positive end-expiratory pressure (PEEP), andderecruitment of the lung alveoli.

The system 10 includes a closed suction cleaning device module 12 and amanifold 13. A distal port of the manifold 13 is illustrated as beingcoupled to an endotracheal tube 14. Endotracheal tubes typically vary insize between about 2.0 mm internal diameter and 9.0 mm internaldiameter. Pediatric and neonatal-sized tubes typically have an internaldiameter of less than 7 mm, such as between 2.0 and 6.5 mm. The distalport 11 of the manifold (e.g., a variable size connector) can be sizedas appropriate to match the internal diameter of the endotracheal tube14 to which it is being connected. The distal port 11 reversibly couplesto the manifold 13 and is chosen from a variety of available sizes toaccommodate endotracheal tubes of various diameters. In one embodiment,the distal port 11 is coupled to the endotracheal tube 14 using auniversal endotracheal tube connector (e.g., via friction-fit coupling).The manifold 13 also includes a standard size ventilator connection port15. The illustrated embodiment of the manifold 13 also includes twoadditional ports, a flush port 16 and a main instrumentation port 17.The main instrumentation port 17 is illustrated as being in-line withthe distal port 11 but may be arranged at an angle in other embodiments.As shown, the closed suction cleaning device module 12 is removablycoupled (e.g., via friction-fit coupling or mechanical interlockingcoupling mechanisms) to the instrumentation port 17 and includes asleeve, or sheath, 121 to prevent against contamination. The closedsuction cleaning device 12 and the manifold 13 may incorporate any ofthe structural or functional features of the corresponding devices orcomponents (e.g., closed suction devices 3200, 3300, 3400, 3500 andmanifolds 3010, 4830, 5030, 5232) described and/or illustrated in PCTPublication No. WO 2015/187583 or described and/or illustrated herein.The sleeve, or sheath, 121 may incorporate any of the structural orfunctional features of the corresponding components (e.g., sleeve 3090)described and/or illustrated in PCT Publication No. WO 2015/187583 ordescribed and/or illustrated herein. The system may also be adapted foradult-sized systems.

The manifold 13 includes a manifold occluder 18 (e.g., stopcock, shutoffmember, barrier) adapted to occlude the manifold 13 (e.g., block airflow from the ventilator port 15 to the instrumentation port 17 or flushport 16 and/or block insertion of instrumentation into the endotrachealtube 14 through the distal port 11) in a closed configuration. As shown,the manifold occluder 18 is positioned immediately adjacent to theventilator connection port 15. The manifold occluder 18 is shown in theopen position, or configuration. When the manifold occluder 18 is in theopen configuration, a closed suction catheter 19 of the closed suctioncleaning device module 12, an endotracheal tube cleaning device (e.g.,catheter), or other catheters, scopes, or instruments can be insertedinto the endotracheal tube 14 through the manifold 13 (e.g., in throughinstrumentation port 17 and out through distal port 11). When themanifold occluder 18 is toggled (e.g., rotated) to the closed position,or configuration, no catheters or other instruments can pass into theendotracheal tube 14 through the manifold 13.

FIGS. 6A and 6B illustrate an embodiment of a manifold 613 (which may besimilar to manifold 13 or replace manifold 13 in system 10) in a closedconfiguration and an open configuration, respectively. In use, accordingto some embodiments, a suction catheter, an endotracheal tube cleaningdevice, a visualization device and/or other device or instrument isadvanced through an instrumentation access port 617 of the manifold 613and out the distal port 611 connected to an artificial airway (e.g.,endotracheal tube) or other body-inserted tube while the occluder is inan open configuration (as shown in FIG. 6B). After the cleaning and/ordiagnostic procedure is performed using the suction catheter,endotracheal tube cleaning device, visualization device and/or otherdevice or instrument, the device or instrument can be withdrawnrearwardly or cephalad through the manifold 613 such that the distal tipof such device or instrument resides just proximally to the occluder618, which may then be closed by rotating a handle or knob 614 of theoccluder 90° to the closed configuration (as shown in FIG. 6A). As shownin FIGS. 6A and 6B, the manifold occluder 618 may include a barrier orsealing member 619 coupled to the handle or knob 614 such that rotationof the handle or knob 614 causes rotation of the barrier or sealingmember 619. The barrier or sealing member 619 may be sized and shaped soas to match a shape of the inner curved surface of the manifold 613 soas to effectively seal off the portion of the manifold 613 proximal tothe barrier or sealing member 619 from fluid penetration or pressureloss or leakage when the barrier or sealing member 619 is in the closedconfiguration and so as not to hinder insertion of instruments throughthe manifold when the barrier or sealing member 619 is in the openconfiguration. The manifold occluder 18 described herein may incorporatethe structural and functional features of the occluder 618 or may besubstituted with the occluder 618 as illustrated in FIGS. 6A and 6B.

The manifold occluder 18, 618 and its positioning advantageously reduces(e.g., minimizes) the ventilation dead space in the manifold 13, 613 andthus, in the ventilatory circuit. In accordance with severalembodiments, by designing the manifold occluder 18, 618 (e.g., stopcock,shutoff member or valve, barrier) in such a manner that it rotatestoward the patient, the dead space can advantageously be reduced to theabsolute minimum required and would be as if there were only aventilator connection present and not another branch or port forming a“Y”, which other branch or port leads to a catheter interface, therebyreducing or eliminating unnecessary dead space, and thereby improvingthe efficiency of the breathing or ventilatory circuit. In the intubatedneonate, physiologic dead space is the sum of the breathing apparatus,the airways, and any non-perfused alveoli. Neonates are particularlysensitive to the impact of breathing apparatus volume added to theventilatory circuit, as even small increases in apparatus dead space cansignificantly increase PCO₂ or the minute ventilation needed to maintaina normal PCO₂. This dead space issue applies to the Y connection of themanifold to the endotracheal tube as well as other more proximal partsof the ventilatory circuit. For neonates with small lung capacity, anyresistance, turbulence or breathing inefficiency that can be eliminatedor reduced is helpful to the patient, and can advantageously prevent theclinician from having to increase ventilation pressures to try toaccommodate for losses due to dead space in the manifold (e.g., manifold13, 213, 613). The manifold occluder 18 may comprise a stopcockmechanism or other suitable shut-off mechanism (e.g., positive,continuous, physical barrier) adapted to have a closed configuration inwhich the passageway is blocked and an open configuration in which thepassageway is open.

Elevated tidal volume, minute ventilation, and peak inspiratory pressurecorrelates directly with the severity of broncho-pulmonary dysplasia inpreterm infants. Therefore, current approaches to lung protectiveventilation mandate that tidal volume and respiratory rate be limited tominimize the risk of ventilator-induced injury. When employing a lungprotective ventilation strategy, apparatus dead space, including thedead space in the manifold (e.g., Y connector) should be minimized toavoid unnecessary hypercarbia or excessive minute ventilation, inaccordance with several embodiments. FIG. 7 illustrates a conventionalprior art manifold 713 having a distal port 711 and two proximal ports715, 717 that form “Y” branches. As shown in FIG. 7, the conventionalprior art manifold 713 has a dead space region extending from at leastthe intersection of the “Y” branches 715, 717 with the main body of themanifold 713 to the irrigation port 757 of the suction catheter module712 including a suction catheter 719. As shown in FIG. 8, the manifoldsdisclosed herein (e.g., manifold 13, 213, 613) advantageously allow fora positive close off of potential dead space in the Y connector proximalto the intersection of the two branches (e.g., ventilation port 615 andaccess port 617) of the Y, thereby helping to minimize the requiredtidal volume and minute ventilation of intubated neonates in order tomaintain normal PCO₂. The design of the close-off feature 618 (e.g.,stopcock or solid, physical barrier or occluder that can be rotated inand out of its occlusive or blocking configuration) allows predictableisolation of the access port 617 of the manifold (e.g., manifold 13,213, 613) from the ventilatory circuit and the distal port 611,minimizes dead space within the Y connector portion of the manifold(e.g., manifold 13, 213, 613) as much as possible, and is small andlight. In addition, the positive close off feature 618 of the manifold,as opposed to a “diaphragm valve” or “trap door”, allows cleaning ofdevices without saline aspiration, and removal and reconnection ofmultiple devices from the manifold (e.g., manifold 13, 213, 613) withoutinterrupting the patient/ventilatory circuit. This preserves tidalvolume and positive end expiratory pressure and prevents alveolarderecruitment, and can also advantageously reduce the likelihood ofclinicians increasing ventilator pressures to account for loss ofpositive pressure due to dead space.

Referring back to FIG. 1, also when in the closed configuration, salineor other solutions (antimicrobials, etc.) can be introduced through theflush port 16 and suctioned into the closed suction catheter 19. Valvesat the proximal portion of a flush port 16 or a connection member 161coupled to the flush port 16 and/or the distal portion of the closedsuction catheter 19 enclosure may advantageously prevent loss of tidalvolume, airway pressure, or PEEP when endotracheal tube cleaning,instrumentation, or closed suctioning is being performed. The valvedflush connection member 161 or flush port 16 can be used to introduce orinfuse saline or other solutions such as anti-microbials into the closedsuction cleaning device module 12 or the Y connector portion of themanifold 13.

The main instrumentation port 17 or the valved flush connection or flushport 16 can also be used to insert an endotracheal tube cleaningcatheter (e.g., a catheter having an external diameter of about 2.0 mmwith one or more expandable cleaning members positioned along an outersurface of the catheter such as shown in FIG. 2), a visualizing scope(e.g., a scope having an external diameter of about 2.0 mm), or anothercatheter for introduction of irrigation, light therapy, or othertherapeutics to the distal lung fields (such as surfactant to treatimmature lungs). Once any of these catheters or instruments arewithdrawn, the manifold 13 can be closed off by rotating the occluder 18in the direction of the illustrated arrow in the close-up view of FIG.1A, the catheter or instrument can be completely withdrawn from theflush port 16 or main instrumentation port 17, and the space proximal tothe site of the distal manifold closure (e.g., the occluder 18) can beirrigated and cleaned with the irrigant being suctioned into the closedsuction catheter 19. The catheter or instrument (e.g., endotracheal tubecleaning catheter) can be flushed, capped and/or discarded asappropriate per their instructions for use. The flush port 16 may alsobe capped with a cap 162 (tethered or untethered) when not in use. Insome embodiments, the flush port 16 is not a port of the manifold 13 andthe manifold 13 just has the ventilator port 15 and the maininstrumentation port 17 to form a single Y with the distal port formingthe bottom of the Y. The flush port 16 instead may be a component of theclosed suction cleaning device module 12 (as shown, for example, inFIGS. 2B and 8).

In some embodiments, an endotracheal tube cleaning device (e.g., module)is transiently exchanged for the closed suction catheter module 12 orthe suction catheter 19 through the main instrumentation port 17, theendotracheal tube 14 then being effectively cleaned, and theendotracheal tube cleaning device (e.g., module) is then removed fromthe manifold 13 and stored off-line (e.g., no longer coupled to themanifold 13) and the closed suction cleaning device module 12reconnected to the endotracheal tube 14 (e.g., via the instrumentationport 17 of the manifold 13). In other embodiments, an endotracheal tubecleaning device is inserted into a side port (e.g., flush port 16) ofthe manifold 13, the endotracheal tube is then effectively cleaned, andthe endotracheal tube cleaning device is then withdrawn from themanifold 13, all without breaking the ventilatory circuit (and thereforealways maintaining desired tidal volume, pressure, and PEEP (alveolarpressure in the lungs)). In some embodiments, the suction catheter 19comprises an endotracheal tube cleaning member such that a single deviceprovides suction and endotracheal tube cleaning. However, in accordancewith several embodiments, such a single device may not be possible forpediatric or neonatal-sized endotracheal tubes due to size constraints.

FIG. 2 illustrates an embodiment of an endotracheal tube cleaning device20, which may form a module that can be reversibly or removably coupledto the manifold 13 similar to the suction catheter device module 12. Theendotracheal tube cleaning device module 20 and the suction catheterdevice module 12 may be interchangeable to facilitate more effectivecleaning by using both suction and wiping cleaning mechanisms to clearout the endotracheal tube instead of suction alone. The endotrachealtube cleaning device 20 may include a syringe 21, a proximal connector22, a sheath 23, an elongate shaft 24, an extension member (e.g.,proboscis) 25 and a distal connector 26. The proboscis 25 isadvantageously constructed to provide a close-fitting column throughwhich the flexible catheter shaft 24 of the endotracheal tube cleaningdevice 20 may be passed and shall be of a sufficient length to providecolumn strength support from the exterior. In addition, the proboscis 25is advantageously constructed to have an exterior surface areasufficient to collect the protective sheath 23. The protective sheath 23is advantageously constructed to be substantially flexible and pliableand thus tends to collect in such a way that it would interfere with theinsertion of the substantially flexible catheter shaft 24 of theendotracheal tube cleaning device 20. The proboscis 25, providesadditional column strength for the flexible catheter shaft 24 of theendotracheal tube cleaning device 20 as well as a collection area toprevent interference from the protective sheath 23. As shown, the outerdiameter of the proboscis 25 increases from its proximal end to itsdistal end (forming an overall frustoconical shape). The syringe 21provides inflation or other expansion of a distal cleaning member (e.g.,wiper) 27, the outside diameter of which is small enough to insert intoand clean the lumen of an endotracheal tube as small as 2.0 to 2.5 mm.In some embodiments, the syringe 21 is color-coded to the size of theendotracheal tube and the size of the endotracheal tube is printed orotherwise included somewhere on the device 20 (e.g., at the connectionof the syringe 21 to the elongate shaft 24). A hole 28 in a barrel ofthe syringe 21 allows precise control of the air volume sent through apilot channel (not shown in FIG. 2 but shown in FIGS. 3A and 3B) of theelongate shaft 24 of the cleaning device 20 to the distal cleaningmember 27. In some embodiments, the syringe 21 is permanently adhered tothe proximal connector 22 to prevent syringes of differing volumes frombeing inadvertently connected to the elongate shaft 24. In otherembodiments, the syringe 21 is removable from the proximal connector 22.

The elongate shaft 24 of the cleaning device 20 includes a pilot channel32 (shown in FIGS. 3A, 3B) for inflation or other expansion of thecleaning member 27 and may have additional channels for other purposes(e.g., irrigation, photodynamic light therapy, visualization, suction oraspiration, delivery of drugs, anti-microbials or other therapeutics).In accordance with several embodiments, the elongate shaft 24 isadvantageously co-extruded with an element or material that differs incomposition from the elongate shaft 24 itself in order to achievevarious purposes, such as column strength and pushability, curvature,limited stretch, light transmission or other desired characteristics.The endotracheal tube cleaning device 20 may incorporate any of thestructural or functional features of the corresponding devices orcomponents (e.g., cleaning devices 3210, 4110) described and/orillustrated in PCT Publication No. WO 2015/187583 and/or the devicesdescribed and/or illustrated herein. Although described herein as beinginflatable, the cleaning member 27 may be expanded by non-inflatablemeans. For example, in some embodiments, the cleaning member 27 canincorporate any of the mechanically-expandable cleaning members or othercleaning members disclosed in U.S. Publ. No. 2011/0023885, U.S. Publ.No. 2013/0104884, and PCT Publ. No. WO 2011/126812, the entireties ofeach of which are hereby incorporated by reference herein, such as amechanically-actuated scaffold (e.g., a mesh scaffold actuated bymovement of two concentric tubes attached to opposite ends of the meshscaffold with respect to each other). The endotracheal tube cleaningdevice 20 may be adapted for use with neonate-sized, pediatric-sized oradult-sized endotracheal tubes. The sheath 23 and proboscis 25 may beoptional and only included for closed systems.

FIG. 2A illustrates a cross-section view of an embodiment of a connector200 (e.g., distal connector 26 of cleaning device 20 of FIG. 2) adaptedto removably couple to an endotracheal tube (e.g., endotracheal tube 14)or a manifold (e.g., manifold 13) via friction-fit engagement. Theconnector 200 includes a distal connection member or end portion 201having a tapered profile or configuration (e.g., conical shape) with anouter diameter sufficient to reliably engage the endotracheal tube ormanifold such that there are no leaks (e.g., air leaks or pressureleaks) or unintended disconnections. The outer cross-sectional dimensionof the distal connection member or distal end portion 201 decreases fromproximal to distal and the inner cross-sectional dimension increasesfrom proximal to distal. The connector 200 includes a conical cavity orarea 202 inside the tapered distal connection member 201 adapted toallow a catheter of a cleaning device 203 (e.g., elongate shaft 24 ofcleaning device 20 with cleaning member 27) to be fully retrieved andthe biofilm collected without worrying about collected biofilm beingscraped off from the cleaning device (e.g., from cleaning member 27)while the cleaning device 203 is pulled back into the connector 200. Theconnector 200 may also include a flush port 204 adapted for rinsing thecleaning device with a syringe or other fluid filled device underpressure to remove debris retrieved by the cleaning device and retainedinside the cavity 202. The generally conical shape of the area 202 (withthe inner diameter being larger at the distal end than at the proximalend where the flush port 204 branches off) advantageously allows thepressure gradient of irrigation to be highest at the flush port 204 andlowest at the distal terminus. This pressure gradient helps move thedebris from the narrowest part of the conical area 202 to the outside ofthe connector 200 through the opening at the distal tip of the connector200. The connector 200 may optionally include a notch, groove,indentation or other retention feature 205 on an area on the outsidediameter of the connector 200 adapted to retain a tethered cap or othertethered part (not shown). A circumferential seal 206 (e.g., valve,diaphragm) is included in a main lumen of the connector 200 that isadapted to prevent leaks in the ventilatory circuit and to wipe theelongate shaft (and/or cleaning member) of the cleaning device (or otherinstrument) clean upon retrieval back into the connector 200. For use ina closed system, the connector 200 includes an area (e.g., slot 207) onits outside diameter adapted to receive and retain at least a distalportion of a protective sheath (e.g., sheath 23). In some embodiments, aproximal end 208 of the connector 200 is sized and shaped to mount anextension member, or proboscis (e.g., extension member 25).

In accordance with several embodiments, the connector 200 facilitatescollection of retrieved biofilm (e.g., debris, secretions), therebyminimizing the biofilm left behind after a therapeutic or diagnosticprocedure (e.g., cleaning, clearing, wiping, visualization procedure).In some systems, the system (e.g., connector 200, cleaning device 20) isdesigned to be flushed under pressure for cleaning and reuse of thesystem on the same patient over an extended period of time (e.g., 24-72hours).

FIG. 2B illustrates an embodiment of a system 250 that includes acleaning device module 255 (e.g., cleaning devices or modules 12, 20)and a manifold 213, wherein the system 250 is adapted to allowinterchangeable connection of catheters or modules (e.g., suctioncatheter module, bronchoscopic module, bronchoalveolar lavage cathetermodule, integrated suction and wiper cleaning catheter module,endotracheal tube cleaning device module, etc.) without loss of pressureor a break in ventilatory circuit.

The manifold 213 includes a distal connection member 214 adapted tocouple to or interface with an endotracheal tube or other body-insertedtube (neonatal size, pediatric size or adult size). The manifold 213also includes a rotatable or otherwise-actuated stopcock 218 adapted toshut or close off an instrumentation port 216 of the manifold 213 fromthe ventilatory circuit connected to the ventilator port 215. Thestopcock 218 may incorporate any of the structural and/or functionalfeatures of the manifold occluder 18 described herein. The cleaningdevice module 255 includes a distal connector 200B (e.g., distalconnector 26, 200) and a protective sheath 253 (e.g., sheath 23). Thedistal connector 200B includes a distal connection member or distal endportion 256, a flush port 257 (e.g., flush port 204) and an extensionmember or proboscis 258 (e.g., extension member or proboscis 25). Theillustrated distal connection member or distal end portion 256 comprisesa conical-shaped connection member adapted to removably couple to themanifold 213. Although illustrated as a closed catheter module, thecleaning device module 255 may be interchanged with another closed oropen cleaning module or diagnostic module (e.g., suction cathetermodule, bronchoscopic module, bronchoalveolar lavage catheter module,integrated suction and wiper cleaning catheter module, endotracheal tubecleaning device module, etc. such as described herein or in WO2015/187583, the entire contents of which is hereby incorporated byreference herein.

In accordance with several embodiments, the system 250 described inconnection with FIG. 2B advantageously facilitates modular connectionsof small diameter devices into a ventilatory circuit such that deadspace is minimized and cleaning/flushing of devices (e.g., cleaning orsuction catheters or visualization devices) can be performed inreal-time without exposing the patient to negative pressures and/orwithout disconnecting the patient from a ventilator circuit. Theconical-shaped connection member or distal end portion 256 to thestopcock 218 may advantageously be designed (e.g., shaped and sized) tofully engage the manifold through the stopcock 218, thereby reducing(e.g., minimizing) dead space and providing a reservoir for collectionof biofilm (e.g., debris, secretions) removed from the endotracheal tubeor other body-inserted tube, in accordance with several embodiments. Thesystem 250 may be used for neonate-sized, pediatric-sized or adult-sizedendotracheal tubes and modules.

FIGS. 3A AND 3B illustrate a portion of an embodiment of the elongateshaft 24 that includes a coextruded material 30 of a different materialthan the material of the elongate shaft 24 (before and after a curingprocess, respectively). In some embodiments, the coextruded material 30(and thus the elongate shaft 24) may be manufactured to have a naturalcurved configuration after a curing process. In accordance with severalembodiments, the curvature of the catheter shaft 24 is beneficial,desirable, and incorporated into the coextrusion process so as toproduce an intentional curve to the cleaning device. The curvature mayfacilitate introduction into ports of manifolds or into particularairways of the trachea-bronchial tree. In some embodiments, the naturalcurvature is achieved by a specially-controlled co-extrusion process forsilicone or other material over a solid or twisted member and a curingprocess for the silicone or other material which biases the extrusion ina particular curvature direction advantageous for insertion into asimilarly curved tube (e.g., an endotracheal tube). FIGS. 3A and 3Billustrate the one or more channels 32 (e.g., a pilot channel forinflation and/or other accessory channels) extending along the length ofthe elongate shaft 24. In some embodiments, the catheter shaft 24comprises an extruded silicone catheter; however, other materials may beused as desired and/or required. The coextruded material 30 may comprisea wire that is co-extruded with at least a portion of the length of theshaft 24 of the catheter and is adherent to the shaft along its length.In one embodiment, the wire is braided. As shown in the illustratedembodiment, the wire does not extend all the way to the distal tip ofthe catheter in order to prevent possible injury that might be caused bythe wire should it protrude from the distal tip of the catheter duringuse. In some embodiments, the wire provides, facilitates or increasespushability to the catheter as it is inserted and prevents or otherwisereduces stretching or snapback when the catheter is removed from abody-inserted tube (e.g., endotracheal tube). In other embodiments, asolid wire or mandrel may be coextruded to provide increased pushabilityand malleability. In some embodiments, a flexible tube (nylon, Teflon,PEEK, polyamide, etc.) may be used to provide or increase pushability,prevent or reduce stretch or snapback and provide an alternate fluidpath for delivery of medicaments (chlorhexidine) or fluids (saline). Thecoextrusion may be particularly advantageous for small diameter,flexible catheters (such as silicone catheters designed for neonate orpediatric patients). If improved pushability is not required or desired,the catheter shaft 24 may be coextruded over another stretch-limitingmaterial, such as suture, string, filament or other material. Additionaldetails regarding coextrusion may be found in PCT Publication No. WO2015/187583 (see, e.g., Paragraphs [0043], [0149], [0158], [0165] and[0185]) and/or as otherwise described herein.

FIG. 4 illustrates a close-up view of the distal end portion of thecleaning system of FIG. 2 that shows the extension member, or proboscis,25 extending into the sheath 23. The extension member 25 (which may betubular or cone-shaped in various embodiments) may extend from thedistal connector 26 into the sheath 23 to advantageously allow forincreased shaft column strength and pushability, as well as serving as acollection site for the collapsible sheath 23 as the elongate shaft 24of the cleaning device 20 is inserted into the distal connector 26. Theextension member 25 may also allow the sheath 23 to be pulled onto thedistal connector, or collection tube, 26 and therefore pull the shaft 24into the endotracheal tube as the sheath 23 is collected.

In accordance with several embodiments, the proboscis component providesadditional column strength to a tube as that tube is pushed or insertedinto another tube, cavity, valve, seal, orifice or other applicationwhere the soft nature of the inserted tube is desired for certain designor safety considerations (e.g., need for a silicone balloon forproximity to tissue or structures that might be damaged by a more rigidcatheter) that renders the tube difficult to push due to a lack ofcolumn strength (e.g., the tube meets resistance and folds over ontoitself or kinks). The additional column strength provided is related tothe fit between the proboscis 25 and the catheter, as well as the lengthof the proboscis relative to the length of the catheter and differentresults can be achieved by changing these dimensions. In someembodiments, the proboscis 25 provides a mechanism to remove aprotective sheath (e.g., sheath 23) out of interference from a catheterin the systems or devices described herein. For example, in many medicalor industrial applications it is desirable to protect the user fromcontaminants in the system they are addressing with the device. Aprotective barrier (e.g., sheath) is desirable. In some embodiments, thesheath (e.g., sheath 23) can interfere with the insertion of a catheterbecause it tends to bunch or collect near the insertion point. As thesheath collects (e.g., bunches), the friction and resistance toinsertion increases and in some cases hinders the insertion of acatheter (particularly if the catheter has low column strength). Theproboscis may advantageously be used to collect the sheath and keep itfrom bunching around the catheter at the insertion point therebyreducing or eliminating resistance to insertion and allowing anotherwise unusable soft catheter to be utilized.

In some embodiments, a circumferential seal 29 (e.g., pucker valve orother diaphragm or valve or seal member) within the distal connector 26is adapted to prevent air and secretions from collecting within thesheath 23. FIG. 4 also illustrates a pilot channel 40 for inflationextending along a length of the elongate shaft 24. Additional channelsmay be included as well (e.g., for irrigation, aspiration, fluiddelivery, drug delivery, microbicidal delivery, light delivery,visualization scopes or devices).

Referring back to FIG. 2, the distal connector 26 may comprise a housingand a distal end portion (e.g., connection member) that is sized andadapted to fit into a port of a manifold connector (e.g.,instrumentation port 17, 217 of manifold 13, 213, 613). The endotrachealtube cleaning device or module 20 may thus transiently orinterchangeably replace a closed suction catheter (e.g., suctioncatheter device module 12) in order to clean the endotracheal tube orother body-inserted tube. In some embodiments, the endotracheal tubecleaning device or module 20 can be sized to transiently connect througha side port of a manifold (e.g., manifold 13, 213, 613) of a closedsuction system (as described in connection with FIG. 1) to clean theendotracheal tube.

A flush port 280 connected to the distal connector 26 can be used toflush removed secretions from the cleaning member 27 out the end of thecleaning device 20. A tethered cap 281 can be used to maintain closureof the end of the cleaning device 20 (e.g., module) when off-line (e.g.,when not coupled to a ventilator manifold). The cap 281 canadvantageously be sized to also cap the closed suction catheter duringthe time it is removed from the manifold (e.g., manifold 13) andreplaced by the cleaning device 20 (e.g., module).

Markings or indicia 260 may be provided or included on the elongateshaft 24 to help determine appropriate positioning within theendotracheal tube to be cleaned by matching the markings 260 to the ISOstandard markings on the outside of the endotracheal tube.

Turning to FIG. 5, modular cleaning devices (e.g., closed suctioncatheters and/or endotracheal tube cleaning devices adapted to beremovably coupled to ventilator manifolds) or other instrumentation(e.g., scopes) designed for insertion within body-inserted tubes may bestored off-line (e.g., remotely or at least not coupled to the manifold)for variable periods of time when not in use and not actively connectedto the ventilator manifold. These catheters, instruments, cleaningdevices, and scopes may be cleaned before being disconnected from theventilator manifold by instilling or infusing saline or antimicrobialsolutions into a flush port of the modular connector and suctioning thefluid out of the cleaning chamber until the device is visibly clean.However, the instruments may not be adequately cleaned by irrigation orflushing alone.

FIG. 5 illustrates an embodiment of a sterilization cap 50. Inaccordance with several embodiments, the sterilization cap 50 of FIG. 5can be placed over the end of any module (e.g., suction cathetercleaning module 12, endotracheal tube cleaning device module 20,visualization device module, etc.) being disconnected from theventilator manifold (e.g., manifold 13, 213, 613) of an airwaymaintenance system (e.g., system 10) for off-line storage such that thecap 50 can be used to sterilize the device (catheter, cleaner, scope,instrument) while the device is disconnected and stored. In accordancewith several embodiments, use of such a sterilization cap 50 canadvantageously prolong the time period that any module of the airwaymaintenance system may be used (e.g., 72 hours or longer).

In accordance with several embodiments, the sterilization cap 50 isadvantageously sized and adapted to fit over the distal end of allmodules and adapters with a positive engagement, thereby providing a“one-size-fits-all” solution. In the illustrated embodiment of FIG. 5,the module is shown as the endotracheal tube cleaning module 20 butcould also be a closed suction cleaning module (e.g. suction catheterdevice module 12) or other module.

The sterilization cap 50 includes an on-off switch 51, one or more powersources 52, one or more light sources 53 and a window 54. In someembodiments, positive engagement is required before the function of theon-off switch 51 is able to be activated. The one or more power sources52 may comprise disposable or rechargeable batteries or other powersources or energy storage devices (e.g., capacitors or other electricalor electrochemical energy storage devices). The one or more powersources 52 may also comprise a wired electrical source. For embodimentsin which rechargeable batteries are contemplated, the sterilization cap50 includes a recharge interface adapted to receive a charging componentor mechanism. In some embodiments, the one or more light sources 53comprise light-emitting diodes (LEDs). In embodiments in whichultraviolet wavelength LEDs are used for the light sources 53, thewindow 54 may comprise a quartz window adapted to allow the LEDsutilizing microbicidal UV-C wavelengths to deliver such light to theinside of the removed module, including to the catheter, scope or deviceinside. Although the quartz window 54 passes the UV-C light, the UV-Clight is completely absorbed by the modular materials (e.g., plasticmaterials) such that no external UV-C energy is delivered to theexternal environment, the patients, or end users. In some embodiments,the sterilization cap 50 and the one or more light sources 53 areconfigured to provide photodynamic therapy. For example, a photodynamictherapy solution can be injected into the module to be cleaned and thenthe solution can be suctioned out so that the surfaces of the module tobe cleaned are coated. The one or more light sources 53 may then beactivated to sterilize the module.

In some embodiments, the one or more power sources 52 are chosen asneeded to deliver the appropriate wavelength (e.g., 200 nm-280 nm, 200nm-260 nm, 200 nm-240 nm, 220 nm-280 nm, 240 nm-280 nm, 220 nm-260 nm,overlapping ranges thereof, or any value within the recited ranges) forthe appropriate amount of time (e.g., 1 second to 30 minutes, 1 secondto 2 minutes, 1 second to 30 seconds, 5 seconds to 30 seconds, 10seconds to 1 minute, 30 seconds to 90 seconds, 30 seconds to 2 minutes,1 minute to 5 minutes, 2 minutes to 10 minutes, 5 minutes to 15 minutes,10 minutes to 30 minutes, 15 minutes to 30 minutes, overlapping rangesthereof, or any value within the recited ranges) at the appropriatepower or energy level in order to sterilize the catheter, device, andinside of the module. In some embodiments, the energy delivered iswithin a range of between 1 and 150 mJ/cm² (e.g., between 1 and 25mJ/cm², between 10 and 50 mJ/cm², between 50 and 100 mJ/cm², between 50and 150 mJ/cm², between 1 and 100 mJ/cm², between 10 and 100 mJ/cm²,overlapping ranges thereof, or any value within the recited ranges). Inembodiments where batteries are used for the one or more power or energysources, the sterilization cap 50 may be configured to provide anindication or alert to a user that a battery change or charge isrequired. The sterilization cap 50 may thus include one or moreindicator lights or audible sound or tactile haptic outputs.

The on-off switch 51 may optionally include a timer to control aduration of time that the sterilization cap 50 is providing activesterilization. The timer can be set to a specific amount of timeaccording to the requirements for sterilization. In some embodiments,the on-off switch 51 may be able to be turned on only when the cap 50 ispositively engaged with the module to be sterilized. The on-off switch51 may be advantageously designed so that it can be activated after thecap 50 and module have been placed into an off-line (e.g., off-site, orremote) storage bag. In some embodiments, the on/off function isautomatically triggered by the positive engagement of the cap 50 withthe module as described above. In some embodiments, there is anindicator light to alert the user that the device is functioning. Insome embodiments, there is an indicator light (which may be the samelight as the device functioning indicator light or a different light) toalert the user that the cleaning cycle is complete. The indicators mayalternatively or additionally provide an audible indication and/or avibratory haptic indication.

FIGS. 5 and 5A illustrate two different embodiments of the window 54. Asshown in FIG. 5A, the sterilization cap 50, the window 54 of the cap 50may include projections or protuberances 55 adapted to project orprotrude and extend into the inside of the module being sterilized ifneeded to more effectively sterilize the module and device. The window54 may be advantageously constructed to include prongs, tubes or otherstructures as shown by the illustration in FIG. 5A so as to provide amode of transmission for the UV-C light emitted into a cavity andsurrounding surfaces of a device inside of a module (e.g., endotrachealtube cleaning module 20) that may be perpendicular to the one or morelight sources 53 (e.g., LEDs). Such construction is advantageous tofaster and more complete sterilization of such a device. In someembodiments, the projections 55 may be a tube or plurality of tubes(e.g., quartz cones or tubes). In some embodiments, mirrored surfacesmay be used to transmit (e.g., reflect) light to otherwise unreachableportions of the targeted cleaning area (e.g., cavity of a portion of amodule or device).

FIG. 9 illustrates an embodiment of a cap extension member 5000configured for use with a closed system module (e.g., suction catheterdevice cleaning module 12 or endotracheal tube device cleaning module20). The cap extension member 5000 may be formed integral with orremovably coupled to a cap 5032 that confines a flexible sheath 5026surrounding a suction catheter 5025 at the point of the sheath'sconnection to a ventilating manifold 5030. The cap extension member 5000may be injection molded as part of the manifold 5030 or moldedseparately. The cap extension member 5000 may be formed with areceptacle for mechanically attaching to the cap 5032. The cap extensionmember 5000 may be extruded of a material suitable for plastic bonding(e.g., PVC) and may be bonded to the cap 5032 using solvent (e.g.,cyclohexanone) or adhesive (e.g., cyanoacrylate). The cap extensionmember 5000 comprises a shaft having a length configured to extend intothe flexible sheath 5026. The cap extension member 5000 may be composedof a lightweight and transparent material. For example, the capextension member 5000 may be composed of nylon, PEEK, Teflon, polyamide,PVC, etc. In accordance with several embodiments, the cap extensionmember 5000 advantageously allows an operator to “pull” the suctioncatheter 5025 into the manifold 5030 and body-inserted tube by slidingthe sheath 5028 proximally over the shaft of the extension member 5000rather than requiring “pushing” of the catheter 5025 through the cap5032.

In accordance with several embodiments, the catheter 5025 may be of sucha small diameter as to limit its column strength to such a point that itis impossible to push as the catheter 5025 will simply fold over onitself. Utilizing cap extension member 5000, it is possible to pull thecatheter 5025 rather than push it. As the flexible sheath 5026 is pulledon the cap extension member 5000 and collected, the flexible sheath 5026creates a pulling force that allows the catheter 5025 to advance withoutfolding over on itself. Further, the cap extension member 5000 allowsthe flexible sheath 5026 to be moved out of the way of the catheter 5025such that it prevents the bunching up of the flexible sheath 5026 frominterfering with the advancement of the catheter 5025.

In accordance with several embodiments, the cap extension member 5000may advantageously allow suction catheters that are soft, pliable, orextremely flexible and have limited pushability to be employed, as wellas suction catheters having smaller diameters (e.g., between 1 mm and 5mm). For example, the cap extension member 5000 may facilitateintroduction of soft, pliable catheters having integrated expandablecleaning members that are designed for cleaning of body-inserted tubessized for neonates or pediatric patients. The cap extension member 5000may also be incorporated in systems without the accessory cap 4955,4855. For example, a tubular extension member operating in the samemanner as the cap extension member 5000 described herein may be used inconnection with any manifold or adapter (or port of a manifold oradapter) for the insertion of soft, pliable catheters or instrumentsand/or or instruments with diameters less than 5 mm (e.g., 2.5 mm) inouter diameter. The extension member (e.g., proboscis) 25 describedherein may incorporate any of the structural or functional features ofthe cap extension member 5000.

FIGS. 10A and 10B illustrate an embodiment of a suction catheter thatincludes an endotracheal tube cleaning portion 3210 along or near itsdistal end. For pediatric and/or neonatal patients, a suction catheterhaving an expandable endotracheal tube cleaning member disposed thereonlikely cannot be used to clean an endotracheal tube sized for suchpatients (e.g., less than 7 mm, less than 5 mm) due to size limitations,in accordance with several embodiments. However, the structural andfunctional features described in connection with FIGS. 10A, 10B and11A-11C related to the endotracheal tube cleaning portion and thesuction catheter cleaning device 3200 may be incorporated into thecleaning member 27 and the endotracheal tube cleaning device module 20described herein instead of being used on a suction catheter. Thesuction catheter device 3200 may also be used for adult-sizedendotracheal tubes (e.g., 7 mm or greater).

In some embodiments, the catheter body 3204 of the device 3200 comprisesone or more side suction holes, openings or ports 3220, 3224 (e.g.,distal alone (3220), distal and proximal (3220 and 3224), or proximalalone (3224)) distal and/or proximal to the cleaning device 3210, asdesired or required. Such side holes, openings or ports 3220, 3224 areconfigured to be in fluid communication with one or more internal fluidpassageways of the catheter body 3204. Further, the distal end 3228 ofthe catheter device can be at least partially open and in fluidcommunication with an interior passage of the catheter body 3204. Thus,suction can be accomplished along one or more different locations of thesuction catheter. The number, size, and positioning of the suctionholes, openings, or ports may be variably altered as part of the suctioncatheter design and manufacture in order to direct varying degrees ofsuction at specific locations along the suction catheter 3204. Inaddition, varying amounts of suction may be applied to the proximal anddistal ports 3220, 3224. Such variations may be required depending onthe overall dimensions and diameter of the suction catheter 3204 and theamount of suction (in mm Hg) intended for delivery at the suction holes,openings, or ports 3220, 3224, thereby allowing for dynamic suctioncontrol. In accordance with several embodiments, a suction catheterdevice comprising suction holes, openings, or ports 3220, 3224 bothproximal and distal to the cleaning portion 3210 advantageouslyfacilitates suction on both sides of the cleaning portion 3210. Suctionholes, openings, or ports 3224 positioned proximal to the cleaningportion 3210 advantageously facilitate suction (and removal) of biofilmor other debris removed by the cleaning portion 3210 (e.g., cleaningmembers or wipers 3240) while the suction catheter device is beingwithdrawn, and may be the only source of suction if the main suctionlumen of the suction catheter device 3200 is occluded by members of thecleaning portion 3210 (such as balloons).

As depicted In FIGS. 10A and 10B, the wiper or cleaning portion 3210 cancomprise one or more distensible or extendable wiper members 3230, suchas, for example, an expandable sleeve, ring or balloon. Such balloons orother distensible members 3230 can be configured to be moved between acollapsed position, where they remain adjacent the catheter body 3204 towhich they are secured (as shown in FIG. 10A), and an expanded position,where they move away from the central axis and the outer diameter of thecatheter body 3204 (as shown in FIG. 10B). As shown, in someembodiments, the cleaning portion 3210 is configured to at leastpartially contact the inside surface of a body-inserted tube (e.g.,endotracheal tube) when the balloon or other distensible or expandablemember 3230 is in the radially-expanded position. Accordingly, as thedevice 3200 is withdrawn (e.g., retracted rearwardly from inside theendotracheal tube or other body-inserted tube), biofilm and/or otherdebris is removed from within the tube. As shown in FIG. 10B, fluid orother air used to selectively expand the balloon or other distensiblemember 3230 can be routed to the interior of the balloon or otherdistensible member 3230 through one or more fluid passages 3260 of thecatheter body 3204 and/or another interior portion of the catheterdevice 3200. In some embodiments, the wiper or cleaning portion 3210 iscomprised of silicone of 50 A-70 A durometer.

With continued reference to FIGS. 10A and 10B, the cleaning portion 3210of the catheter device 3200 comprises one or more cleaning, wiping orshearing members 3240 that are configured to engage and contact theinside wall of the body-placed or body-inserted tube (and/or the biofilmor other debris that has collected therein). For example, in theillustrated embodiment, the balloon or distensible member 3230 consistsof a total of two shaving rings or cleaning members 3240. Such rings orother cleaning members 3240 can extend completely or partially aroundthe circumference of the cleaning portion 3210, as desired or required.The rings or other cleaning members 3240 can have generally square orsharp (e.g., approximately 90°) edges. However, in other embodiments,the cleaning members 3240 comprise more rounded (non-sharp or smooth)profiles. Further, in other embodiments, the cleaning portion 3210comprises more (e.g., 3, 4, 5, more than 5, etc.) or fewer (e.g., 1)rings or other cleaning members 3240. The balloon or distensible member3230 (and thus the cleaning portion 3210) is expanded (e.g., to engagethe inside wall of the body inserted tube and/or the debris accumulatedthereto) by selectively delivering a volume of fluid (e.g., air) to theballoon or distensible member 3230 via one or more “pilot channels” orair or fluid injection channels 3260 attached to or within the catheterdevice 3200.

According to some embodiments, the balloon or other distensible member3230 is secured to the adjacent catheter body 3204 using any attachmentmethod or device, as desired or required. For example, in thearrangement illustrated in FIGS. 10A and 10B, the balloon 3230 isconnected to the catheter body 3204 using one or more adhesive joints3236. Such adhesions or other joints can be located, eitherintermittently or continuously, along any distal, proximal and/orcentral portion of the balloon 3230. In some embodiments, the cleaningportion 3210 (e.g., balloon 3230, cleaning members 3240) and adjacentcatheter body 3204 are composed (partially or entirely) of silicone andthe adhesive joint is achieved with silicone adhesive.

According to some embodiments, the balloon 3230 and/or sleeve membercomprises a generally soft material with memory and recoilcharacteristics such that when fluid or air is withdrawn from theballoon 3230, the cleaning portion 3210 returns to its collapsedposition, immediately adjacent the suction catheter body 3204. In someembodiments, the balloon, wiper or sleeve member comprises a smoothsurface along a portion of or the entire length and does not compriseany shaving rings or cleaning members. The balloon, wiper or sleevemember may comprise one or more of urethane, silicone, PEBAXthermoplastic elastomer, or PVC materials. In some embodiments, theballoon, wiper or sleeve member is comprised of silicone of 50 A-70 Adurometer.

In some embodiments, such a catheter device 3200 is used for suctiononly without expansion of the cleaning portion 3210 (e.g., if used assuction catheter cleaning device module 12 in system 10 describedabove). Alternatively, the device 3200 can be utilized without suctionand with only expansion of the cleaning portion 3210, as desired orrequired. In other embodiments, such devices 3200 advantageously enablea user to perform both (e.g., simultaneous) suctioning and cleaning ofthe body-inserted tube (e.g., endotracheal tube) via expansion of thecleaning portion 3210 and balloon or other distensible member 3230. Inother embodiments, when the catheter device 3200 is withdrawn from thebody inserted tube after expansion of the cleaning portion 3210, biofilmor other debris removed from the inside walls of the body-inserted tubethat has collected proximally to the cleaning portion 3210 is removed bythe application of suction to proximal suction ports 3224. In someembodiments, the suction ports 3220, 3224 may be designed (e.g., byvarying the size, position, number, and suction pressures) to providedynamic control of suction distal and/or proximal to the cleaningportion 3210. In one embodiment, when the balloon or other distensiblemember 3230 is expanded and suction is applied, only the proximalsuction port(s) 3224 are activated.

FIGS. 11A-11C illustrate various views of the suction catheter device3200 positioned within a body-inserted tube (e.g., endotracheal tube)and is provided to show how the cleaning device 27 of endotracheal tubecleaning device 20 could operate as well. As discussed herein, thedevices 20, 3200 can be used in a closed suction system. For example,the device 20, 3200 can be configured to retract within a flexibleenclosure, either with or without a manifold (e.g., manifold 13, 213,613). In such systems, the catheter device 20, 3200 can be selectivelyretracted into a sleeve or sheath. Accordingly, the biofilm, otherdebris and/or other unwanted materials removed from the subject beingtreated can be safely maintained within the sleeve and away from theexposed external environment, thereby allowing the clinician to reusethe device over a particular time period. Further, as discussed, theclinician is provided with great flexibility when using such a device3200, as he or she can choose to use the device 3200 for suction only,for body-inserted tube cleaning only, for cleaning of portions of therespiratory tract or tree, and/or combinations thereof, as desired orrequired.

In several embodiments, the proximal controllers of the suction catheterdevice 3200 described herein independently controls the suction andcleaning portion activation (e.g., expansion) functions, therebyallowing the suction to function independently, the cleaning portion tobe activated and function independently, or neither suction nor thecleaning portion to be activated, as desired or required. In someembodiments, the proximal controller or control unit comprises a lockingmechanism to prevent inadvertent activation of the suction and/ordeployment of the expandable cleaning portion. The locking mechanism mayadvantageously be easy to use and to interpret, thereby reducing usererror and improving user satisfaction. Unintended activation of thesuction could significantly decrease ventilator circuit pressures,volumes, and/or flows, each of which may potentially cause significantadverse effects on an intubated patient. Unintended deployment of theexpandable cleaning member or portion could significantly obstruct theartificial airway (e.g., endotracheal or other body-inserted tube),which could potentially cause significant clinical deterioration if leftdeployed for an extended period of time. In some embodiments, thelocking mechanism is incorporated into the proximal controller orcontrol unit. A portion (e.g., operational guide) of the proximalcontroller or control unit may be rotational or otherwise transitionalin 1, 2 or 3 steps or detents. For example, the operational guide mayrotate between three rotation positions each corresponding to adifferent operational state. In such embodiment, the initial positioncorresponds to an operational state in which suction and activation ofthe cleaning member are both locked or prevented, the second positioncorresponds to an operational state that allows suction only (withactivation of the cleaning portion being locked or prevented), and thethird position corresponds to an operational state that allowsactivation of the cleaning member only (with suction being locked orprevented). In this embodiment, risk of severe negative pressures andmajor atelectasis can be minimized or otherwise reduced. The transitionsbetween the positions may be effected by rotation or other transitionalmovement. For rotational embodiments, continued rotation beyond thethird position may cause transition back to the first position in a fullcircle. In various embodiments, the operational guide advantageouslyfacilitates audible, visual and/or tactile confirmation of a transitionbetween operational states or positions. In some embodiments, bothsuction and cleaning member activation are prevented when theoperational guide is in a transition between the first, second or thirdpositions. The locking mechanism may prevent suction in the initialposition, prevent activation (e.g., expansion) of the cleaning member inthe second position and prevent suction in the third position. Thepositions and corresponding functions are interchangeable in variousembodiments. In some embodiments, only two operational states exist(suction only and combined suction and cleaning member operation).

Although the cleaning devices, methods, and systems described hereinhave been described in connection with the cleaning of endotrachealtubes or other body-inserted tubes or with the suctioning of distalairways of a patient, the embodiments and features described herein canbe used for other medical applications, such as, for example, urologicapplications; endoscopy, laparoscopic applications, orthopedic and spineapplications, and for tubes within the body such as dialysis grafts.

Conditional language, for example, among others, “can,” “could,”“might,” or “may,” unless specifically stated otherwise, or otherwiseunderstood within the context as used, is generally intended to conveythat certain embodiments include, while other embodiments do notinclude, certain features, elements and/or steps. Thus, such conditionallanguage is not generally intended to imply that features, elementsand/or steps are in any way required for one or more embodiments or thatone or more embodiments necessarily include logic for deciding, with orwithout user input or prompting, whether these features, elements and/orsteps are included or are to be performed in any particular embodiment.

Although several embodiments and examples are disclosed herein, thepresent application extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theinventions and modifications and equivalents thereof. It is alsocontemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments may be made and stillfall within the scope of the inventions. Accordingly, it should beunderstood that various features and aspects of the disclosedembodiments can be combined with or substituted for one another in orderto form varying modes of the disclosed inventions. Thus, it is intendedthat the scope of the embodiments herein disclosed should not be limitedby the particular disclosed embodiments described above.

Some embodiments have been described in connection with the accompanyingdrawings. However, it should be understood that the figures are notdrawn to scale. Distances, angles, etc. are merely illustrative and donot necessarily bear an exact relationship to actual dimensions andlayout of the devices illustrated. Components can be added, removed,and/or rearranged. Additionally, the skilled artisan will recognize thatany of the above-described methods can be carried out using anyappropriate apparatus. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with various embodiments can be usedin all other embodiments set forth herein. Additionally, process stepsmay be added, removed, or reordered. The ranges disclosed hereinencompass any and all overlap, subranges, and combinations thereof, aswell as individual numerical values within that range. For example,description of a range such as from about 4 mm to about 7 mm should beconsidered to have specifically disclosed subranges such as from 4 to 6mm, from 5 to 7 mm, etc., as well as individual numbers within thatrange, for example, 4, 5.5, 6, 6.5, 7 and any whole and partialincrements therebetween. Language such as “up to,” “at least,” “greaterthan,” “less than,” “between,” and the like includes the number recited.Numbers preceded by a term such as “about” or “approximately” includethe recited numbers. For example, the terms “approximately”, “about”,and “substantially” as used herein represent an amount close to thestated amount that still performs a desired function or achieves adesired result.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures of the inventions are described herein. It is to be understoodthat not necessarily all such advantages may be achieved in accordancewith any particular embodiment of the invention. Thus, for example,those skilled in the art will recognize that the inventions may beembodied or carried out in a manner that achieves one advantage or groupof advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

NON-LIMITING EXAMPLES OF EMBODIMENTS Embodiment 1

A connector interface comprising a distally-tapered outside end and aproximally-tapered conical inside end for collection, retention, andirrigation cleaning of debris removed from a tube by a catheter or otherinstrument inserted through the connector interface.

Embodiment 2

An endotracheal tube connection manifold comprising a distal endendotracheal tube connection and proximal connections for ventilationand access for interchangeable catheters, comprising a shutoff valve tothe catheter side that substantially eliminates dead space in theventilatory circuit and facilitates cleaning of the catheters withoutlosing tidal volume or positive end expiratory pressure.

Embodiment 3

A microbicidal UVC device adapted to removably couple to a catheter orother device, comprising a proximal end having a UVC source and acoupling mechanism adapted to removably couple to the catheter or otherdevice.

The device of Embodiment 3, further comprising one or more of thefollowing:

-   -   a) a coupling mechanism adapted to prevent energy or light        emission when not connected to a catheter or other device for        cleaning;    -   b) an integrated timer for assuring proper energy or light        emission;    -   c) an indicator light adapted to indicate when the device is        active and/or when a light delivery cycle is complete;    -   d) a recharging interface;    -   e) a low power indicator; and/or    -   f) quartz protuberances (e.g., cones) for transmission of UVC        light deeper into the catheter or other device housing.

What is claimed is:
 1. A system for maintenance of an endotracheal tubehaving an external diameter of less than 5 mm, the system comprising: amanifold comprising: a ventilation port configured to be removablycoupled to a ventilator, an access port configured to be removablycoupled to multiple modules adapted to access and/or treat theartificial airway through the manifold, and a distal port configured tobe removably coupled to the artificial airway, wherein the ventilationport and the access port branch off from the manifold to form a Y shape;and an occluder positioned at or near a location along a length of themanifold at which the ventilation port and the access port branch offfrom a main body of the manifold, wherein the occluder is configured totransition between an open configuration and a closed configuration,wherein the occluder comprises an external knob and an internal barrierextending laterally from the external knob, wherein the internal barrierof the occluder is shaped and sized so as to effectively seal off theaccess port from the remainder of the manifold when the occluder is inthe closed configuration, thereby reducing an amount of dead space of aventilatory circuit within the manifold; a suction catheter moduleconfigured to be removably coupled to the access port of the manifoldand comprising a suction catheter configured to be introduced into theartificial airway through the manifold and to suction out accumulatedbiofilm from the artificial airway; and an artificial airway cleaningdevice module configured to be removably coupled to the access port ofthe manifold and comprising a flexible catheter having a distalexpandable cleaning member, the flexible catheter being configured to beintroduced through the manifold into the artificial airway, wherein thedistal expandable cleaning member is configured to be expanded intocontact with an interior surface of the artificial airway, and whereinthe flexible catheter is configured to be withdrawn from the artificialairway with the distal expandable member in an expanded configuration toremove additional biofilm from the artificial airway.
 2. The system ofclaim 1, wherein the artificial airway is an endotracheal tube having anexternal diameter of less than 5 mm.
 3. The system of claim 1, whereinthe artificial airway is an endotracheal tube having an externaldiameter of less than 3 mm.
 4. The system of claim 1: wherein theartificial airway cleaning device module comprises a syringe, whereinthe flexible catheter of the artificial airway cleaning device modulecomprises a pilot channel extending from the syringe to the expandablecleaning member; and wherein the syringe is adapted to provide a fixedvolume of air sufficient to inflate the expandable cleaning member intothe expanded configuration.
 5. The system of claim 4, wherein a chamberof the syringe comprises a hole positioned at a location along thechamber of the syringe so as to provide the fixed volume of air, therebyproviding controlled expansion and avoiding overexpansion of theexpandable cleaning member.
 6. The system of claim 1, wherein thesuction catheter module comprises a flexible sheath extending from aproximal portion of the suction catheter module to a distal connectorconfigured to couple to the access port of the manifold so as to providea closed suction system.
 7. The system of claim 1, wherein theartificial airway cleaning device module comprises a flexible sheathextending from a proximal connector to a distal connector configured tocouple to the access port of the manifold so as to provide a closedsystem.
 8. The system of claim 7, wherein the artificial airway cleaningdevice module comprises a conical extension member extending from thedistal connector to a location along a length of the catheter, whereinan outer cross-sectional dimension of the conical extension memberdecreases from a distal end of the extension member to a proximal end ofthe extension member, and wherein the conical extension member isconfigured to facilitate entry of the flexible catheter into themanifold and gathering of the flexible sheath such that the flexiblesheath does not substantially interfere with advancement of the flexiblecatheter into the manifold.
 9. The system of claim 1, wherein thebarrier or sealing member is substantially planar so as not to interferewith introduction of instruments when the occluder is in the openconfiguration.
 10. The system of claim 9, wherein the knob is configuredto be rotated 90 degrees to transition between the open configurationand the closed configuration.
 11. The system of claim 1, wherein theartificial airway cleaning device module comprises an irrigation portconfigured to facilitate introduction of irrigating fluid to clean theexpandable cleaning member after the catheter is removed from themanifold.
 12. A method of cleaning an endotracheal tube inserted withina body of a pediatric or neonatal patient without disconnecting thepatient from a ventilator and without removing the endotracheal tubefrom the body, the method comprising: coupling a distal port of amulti-port manifold to an endotracheal tube having an external diameterof less than 5 mm; coupling a first proximal port of the manifold to aventilator; reversibly coupling a suction catheter cleaning module to asecond proximal port of the manifold, the suction catheter cleaningmodule comprising a suction catheter sized to fit within theendotracheal tube; advancing a distal end of the suction catheterthrough the distal port of the manifold and into the endotracheal tube;activating a suction source so as to facilitate removal of biofilm fromthe endotracheal tube through one or more suction ports at the distalend of the suction catheter; decoupling the suction catheter cleaningmodule from the second proximal port of the manifold; reversiblycoupling an endotracheal tube cleaning module to the second proximalport of the manifold, wherein the endotracheal tube cleaning modulecomprises a flexible catheter having an expandable cleaning memberpositioned along a distal end portion of the flexible catheter;performing a cleaning procedure within the endotracheal tube byexpanding the expandable cleaning member into an expanded configurationsuch that at least a portion of the expandable cleaning member is incontact with an interior surface of the endotracheal tube and thenwithdrawing the flexible catheter proximally out of the endotrachealtube with the expandable cleaning member in the expanded configuration;and decoupling the endotracheal tube cleaning module from the secondproximal port of the manifold.
 13. The method of claim 12, furthercomprising introducing fluid through an irrigation port of theendotracheal tube cleaning module to clean the expandable cleaningmember after decoupling the endotracheal tube cleaning module from thesecond proximal port of the manifold.
 14. The method of claim 12,further comprising enabling access to the distal port of the manifoldand the endotracheal tube by causing an occluder of the manifold totransition to an open configuration from a closed configuration prior tothe step of advancing a distal end of the suction catheter through thedistal port of the manifold and into the endotracheal tube, therebyproviding unobstructed access through the manifold.
 15. The method ofclaim 14, further comprising occluding the manifold so as to preventloss of positive end expiratory pressure in a ventilator circuit due todead space in the manifold proximal to a Y junction formed by the firstproximal port and the second proximal port.
 16. A connector interfacecomprising: a distally-tapered outside end; a proximally-tapered conicalinside end for collection and retention of debris removed from a tube bya catheter or other instrument inserted through the connector interface;and a side port positioned along a length of the connector interfacebetween a proximal end and a distal end of the connector interface thatis adapted for providing irrigation cleaning of the catheter orinstrument.
 17. A sterilization device adapted to removably couple to acatheter or other device, the device comprising: a proximal end havingan ultraviolet-C (UV-C) light source; a coupling mechanism adapted toremovably couple to the catheter or other device; a power switch adaptedto prevent light emission when the sterilization device is not coupledto the catheter or other device.
 18. The sterilization device of claim17, further comprising an integrated timer configured to ensure properduration of light emission by the UV-C light source.
 19. Thesterilization device of claim 17, further comprising an indicator lightadapted to indicate when the sterilization device is active and/or whena light delivery cycle is complete.
 20. The sterilization device ofclaim 17, further comprising a recharging interface adapted to rechargeone or more rechargeable power sources of the sterilization device. 21.The sterilization device of claim 17, further comprising a low powerindicator.
 22. The sterilization device of claim 17, further comprisingquartz protuberances adapted to transmit UV-C light deeper into acleaning chamber of the catheter or other device.